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Endoscopic Thyroidectomy Versus Open Thyroidectomy for Papillary Thyroid Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05446441
Recruitment Status : Not yet recruiting
First Posted : July 6, 2022
Last Update Posted : July 6, 2022
Sponsor:
Information provided by (Responsible Party):
Minghua Ge, Zhejiang Provincial People's Hospital

Study Description
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Brief Summary:
Recently, endoscopic thyroidectomy using gasless unilateral transaxillary approach has been proven feasible and safe in several Chinese medical centers. This study is aimed to compare multi-institutional Chinese outcomes of endoscopic thyroidectomy using gasless unilateral transaxillary approach and conventional open surgery.

Condition or disease Intervention/treatment Phase
Thyroid Cancer Procedure: Endoscopic surgery; Not Applicable

Detailed Description:
Most patients with thyroid tumors are effectively treated surgically by practitioners experienced in the techniques of thyroidectomy. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. Endoscopic thyroidectomy using gasless unilateral transaxillary approach which can hide the operative scar was associated with a higher degree of patient cosmetic satisfaction. Recently, endoscopic thyroidectomy using gasless unilateral transaxillary approach has been proven feasible and safe in several Chinese medical centers. In this study, we designed a prospective study comparing multi-institutional Chinese outcomes of endoscopic thyroidectomy using gasless unilateral transaxillary approach and conventional open surgery.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 634 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endoscopic Thyroidectomy Using Gasless Unilateral Transaxillary Approach Versus Conventional Open Thyroidectomy for Papillary Thyroid Cancer: a Prospective, Multicenter, Randomized Controlled Clinical Trial
Estimated Study Start Date : June 28, 2022
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention;
Endoscopic thyroidectomy was performed in a standardized fashion by multi-institutional Chinese experienced surgeons using the same gasless unilateral transaxillary approach.
 Procedure: Endoscopic surgery;
Endoscopic thyroidectomy group is the papillary thyroid carcinoma patient group who underwent endoscopic thyroid surgery using a gasless, trans-axillary approach.
Active Comparator: Control
Conventional open surgery was performed in a standardized fashion by multi-institutional Chinese experienced surgeons.
 Procedure: Endoscopic surgery;
Endoscopic thyroidectomy group is the papillary thyroid carcinoma patient group who underwent endoscopic thyroid surgery using a gasless, trans-axillary approach.


Outcome Measures
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Primary Outcome Measures :
  1. Number of retrieved central lymph nodes [ Time Frame: 1 month after operation ]
    The number of central lymph nodes removed during the operation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years;
  • The pathological type is papillary thyroid carcinoma;
  • Tumor diameter <2 cm；
  • No extraglandular invasion, or minimal extrathyroidal extension invading only anterior thyroid capsule or sternothyoid muscle；
  • cN0 or cN+ without fusion and fixation of metastatic lymph nodes；
  • no obvious contraindication for thyroidectomy ;
  • Good comply with the research visit plan and other program requirements;
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • patients with severe systemic diseases who can not tolerate general anesthesia or routine surgical posture;
  • previous history of neck surgery, radiotherapy or thermal ablation;
  • hyperthyroidism and substernal goiter;
  • dedifferentiated thyroid carcinoma；
  • accompanied with severe thyroiditis.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05446441


Contacts
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Contact: Minghua Ge, Doctor 86057187666666 ext 86057185335800 geminghua@hmc.edu.cn

Sponsors and Collaborators
Zhejiang Provincial People's Hospital
Investigators
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Principal Investigator: Minghua Ge, Doctor Zhejiang Provincial People's Hospital
More Information
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Responsible Party: Minghua Ge, PH.D, Zhejiang Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT05446441    
Other Study ID Numbers: 2022（050）
First Posted: July 6, 2022    Key Record Dates
Last Update Posted: July 6, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Minghua Ge, Zhejiang Provincial People's Hospital:
Thyroid Cancer
Endoscopic surgery
Open surgery
Radical thyroidectomy
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
 Neoplasms by Site
Neoplasms
Head and Neck Neoplasms